- Other severe, acutem or chronic medical or psychiatric condition or laboratory
abnormality that may interfere with the interpretation of study results and, in the
judgement of the investigator, would make the subject inappropriate for this study.

- Treatment with any of the medications that have a potential risk of prolonging the QT
interval or inducing Torsades de Points and the treatment cannot be discontinued or
switched to a different medication prior to starting study drug.

Type of Study:

Study Design:

Outcome Measure:

Phase I: To determine the MTD of TKI258, administered orally on a 5 days on/2 days off schedule to adult patients with advanced or metastatic RCC whose diseases have progressed despite standard therapy or for whom no standard anticancer therapy exists.

Outcome Time Frame:

at end of phase I

Safety Issue:

Yes

Principal Investigator

Novartis Pharmaceuticals

Investigator Role:

Study Director

Investigator Affiliation:

Novartis Pharmaceuticals

Authority:

United States: Food and Drug Administration

Study ID:

CTKI258A2107

NCT ID:

NCT00715182

Start Date:

July 2008

Completion Date:

July 2012

Related Keywords:

Advanced/ Metastatic Renal Cell Cancer

Renal Cell Cancer

Carcinoma, Renal Cell

Name

Location

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